Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means

• US 7,582,063 B2
• Filed: 11/21/2001
• Issued: 09/01/2009
• Est. Priority Date: 11/21/2000
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Malowaniec, Krzysztof D., Wurster, Thomas, Diekmann, Christoph
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Foreman; Jonathan M
• Application Number:
  US10/432,061
• Publication Number:
  US 20040039303A1
• Time in Patent Office: 2,841 Days
• Field of Search: 600/573, 600/575, 600/576, 600/583, 600/584, 606181-183
• US Class Current: 600/584
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: G01N 33/96 involving blood or serum control standard

Abstract

A blood testing apparatus includes a device for withdrawing blood, a membrane-type testing element, an evaluating device, and a display device forming a complete system which can be manipulated as a single piece of apparatus. Multiple testing elements can be inserted into the apparatus and brought successively to a work position for carrying out several measurements. The blood withdrawing device includes multiple pricking elements. One pricking element is pushed through one testing element and pricks the surface of the skin of a user. The pricking position is disposed so that blood withdrawn from the surface of the skin can impinge upon the testing element.

Claims

1. A blood testing apparatus with a blood extraction device, comprising:

a lancing element drive mechanism, a plurality of test means, positioned on a rotatable, disposable device that can be inserted into the apparatus;

a plurality of lancing elements being disposed on the dispoable device such that each of a lancing element perforates through a test means when the drive mechanism acts against a lancing element, each of a lancing element being associated with a test means and prior to actuation each of a lancing element is gripped to the lancing element drive mechanism, electronics for analysis, and a display which form a complete system to be manipulated as a single apparatus, the display configured to display additional evaluation and display functions and comparisons with previously stored measurement or evaluation data, saved if desired and their results displayed if desired, wherein launch of a lancing element is initiated with a contact sensor or with a pressure point mechanism, the plurality of test means being arranged radially around an axis of rotation of the rotatable, disposable device having a circumferential wall section that runs cylindrically on an outer periphery, the test means being positioned in appropriate recesses in a circumferential wall section of the disposable device in a concentric arrangement around the axis of rotation, each of the test means and at least one lancing element having a longitudinal axis that is substantially perpendicular relative to the axis of rotation;

the test means being disposed with surfaces normal in a radial direction with respect to a center of the rotatable, disposable device.

2. The blood testing apparatus from claim 1, wherein the lancing element remains in the test means following the lancing procedure and can be removed with the test means from an operating position in order to position a new test means there.

3. The blood testing apparatus from claim 1 wherein the lancing element is manageably conjoined to the test means and can be inserted together with the test means into the apparatus and can be deployed to an operating position.

4. The blood testing apparatus from claim 1, wherein spent lancing elements and test means can be ejected or brought to a storage and disposal position.

5. The blood testing apparatus claim 1, wherein the apparatus has an essentially circular disc-shaped outer contour.

6. The blood testing apparatus from claim 1, characterized by a safety mechanism which permits initiation of the lancing procedure only when the apparatus is manipulated correctly.

7. The blood testing apparatus from claim 1, wherein the number of test means to be manipulated as a unit is 5 to 75.

8. The blood testing apparatus from claim 1, wherein the number of test means to be manipulated as a unit is 14-28.

9. The blood testing apparatus from claim 1, wherein the at least one lancing element is disposed on the rotatable, disposable device.

10. The blood testing apparatus from claim 9, wherein the rotatable, disposable device comprises a first housing section for the test means and a second housing section for the at least one lancing elements.

11. The blood testing apparatus from claim 9, wherein the rotatable, disposable device has a central recess which has a drive mechanism and an electric-motor propulsion means for one of a carrier and the drive mechanism.

12. The blood testing apparatus from claim 9, wherein the rotatable, disposable device has a spring means to retract the at least one lancing element from the skin surface of the user.

13. The blood testing apparatus from claim 1, wherein the apparatus has oppositely located a lancing position against which to place the skin surface to be lanced and a release position to initiate the lancing procedure by manual actuation of a release button.

14. The blood testing apparatus from claim 13, wherein the apparatus is adapted to be held by a user holding the apparatus at the lancing position and the release button with two fingers.

15. The blood testing apparatus from claim 13, wherein the release button is ergonomically shaped to be grasped by the thumb of a user.

16. The blood testing apparatus from claim 13, wherein the release button has a pressure point which must be overcome in order to release the lancing element.